Safety Trial of Patient Specific Guides for Lumbar Fusion

Not Applicable

• Conditions: Orthopedic Disorder of Spine
• Interventions: Procedure: Navigation; Procedure: Patient Specific Guide

• Registration Number: NCT04751981
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

This is a single centre, non-blinded safety trial. Patients undergoing lumbar fusion will be treated using patient specific guides (PSG) or navigation. Patients requiring lumbar fusion will be treated using conventional surgical methods except when inserting pedicle screws, where half of the patients will be having screws inserted using PSGs. The conventional method of navigation and intraoperative imaging will be used in conjunction with PSGs, to confirm the safety of the guide trajectory. The primary outcome will be screw accuracy measured in degrees from planned trajectory and mm from the planned entry point.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-27
• Study Start: 2021-02
• Study First Submitted QC: 2021-02-08
• Last Update Submitted: 2021-02-08
• Study First Posted: 2021-02-12
• Last Update Posted: 2021-02-12
• Primary Completion: 2023-02
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Age 18 years or over
• Indication for lumbar spine surgery requiring pedicle screw instrumentation through a posterior approach with fusion.
• Recently has or requires a CT-scan of the spine
• No previous spine surgery on the level being used for patient specific guides
• Sufficient understanding of the English language or interpretation assistance available.

Exclusion Criteria

• History of alcohol or drug abuse
• History of psychiatric disorders
• Previous spine surgery adjacent or at the level of the surgery
• Unable to read or comprehend the consent form/letter of information

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navigation	Navigation	Patients randomized into this group will have pedicle screws placed with conventional navigation.
Patient Specific Guide	Patient Specific Guide	Patients randomized into this group will have pedicle screws placed with the aid of patient specific surgical guides.

Primary Outcome Measures

Name	Time	Method
Screw start point deviation	Day 1	Measured as distance in millimeters from the planed start point.
Screw trajectory deviation	Day 1	Measured as the angle in degrees deviated from the planned trajectory

Secondary Outcome Measures

Name	Time	Method
Guide Reliability	Day 1	The reliability of patient specific guides will be measured as the number of cases that used the guides divided by the total number of cases in which guides were planned to be used.
Pedicle Breach	Day 1	Number, location and severity of any pedicle breaches
Adverse Event Rate & Serious Adverse Events	Day 1, Day 3, 6 weeks, 12 weeks, 26 weeks	Measured intra-operatively and post-operatively